Výsledky vyhledávání - "William Siska"

Scientific and Regulatory Policy Committee Points to Consider: Biological Sample Retention From Nonclinical Toxicity Studies

Autor: Arun R. Pandiri, Molly H. Boyle, Adam D. Aulbach, William Siska, Natalie D. Keirstead, Mary Carsillo, Ahmed M. Shoieb, Krista M. D. La Perle, Carole E. Harbison, Bindu Bennet, Torrie A. Crabbs

Publikováno v: Toxicologic Pathology. 50:252-265

Samples of biologic specimens and their derivatives (eg, wet tissues, paraffin-embedded tissue blocks, histology slides, frozen tissues, whole blood, serum/plasma, and urine) are routinely collected during the course of nonclinical toxicity studies.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4a660b59b33db03c5d760cbb0b285235
https://doi.org/10.1177/01926233211049156

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Scientific and Regulatory Policy Committee Points to Consider: Integration of Clinical Pathology Data With Anatomic Pathology Data in Nonclinical Toxicology Studies

Autor: William Siska, Albert Eric Schultze, Daniela Ennulat, Kathleen Biddle, Michael Logan, Adeyemi O. Adedeji, Tara Arndt, Adam D. Aulbach

Publikováno v: Toxicologic pathology. 50(6)

Integrating clinical pathology data with anatomic pathology data is a common practice when reporting findings in the context of nonclinical toxicity studies and aids in understanding and communicating the nonclinical safety profile of test articles i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::098996f3aaac22fbc70685172dc4e8fc
https://pubmed.ncbi.nlm.nih.gov/35852467

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Interpretative considerations for clinical pathology findings in nonclinical toxicology studies

Autor: William Siska, Ara Gupta, Denise Bounous, Holly Jordan, Laura Boone, Allison Vitsky, Adeyemi O Adedeji, Michael R. Logan, Adam D. Aulbach, Laura Cregar, Tara Arndt, Anne Provencher, Niraj Tripathi, Lila Ramaiah

Publikováno v: Veterinary Clinical Pathology. 48:383-388

The interpretation of clinical pathology results from nonclinical safety studies is a fundamental component in hazard identification of new drug candidates. The ever-increasing complexity of nonclinical safety studies and sophistication of modern ana

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f10f4972abd750e087a2f679ab5d85fa
https://doi.org/10.1111/vcp.12773

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Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies

Autor: Ara Gupta, Tara Arndt, Michael R. Logan, Adam D. Aulbach, Anne Provencher, Lila Ramaiah, Laura Boone, Holly Jordan, William Siska, Denise Bounous, Allison Vitsky, Adeyemi O Adedeji, Niraj Tripathi, Laura Cregar

Publikováno v: Veterinary Clinical Pathology. 48:389-399

Clinical pathology reporting practices are diverse among individuals and organizations involved in nonclinical toxicology studies. Clear, informative, and consistent reporting of clinical pathology results increases their value and avoids misinterpre

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::376f0703c947358b5be92ad4c967c485
https://doi.org/10.1111/vcp.12772

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Mercapturate pathway metabolites of sotorasib, a covalent inhibitor of KRASG12C, are associated with renal toxicity in the Sprague Dawley rat

Autor: Jonathan Werner, Benjamin David, Rhian Davies, W. Griffith Humphreys, Thomas M. Monticello, Upendra P. Dahal, Barbara Thomas, Katsu Ishida, William Siska, Min Jiang, Jonathan Stauber, J. Russell Lipford, Jan Wahlstrom

Publikováno v: Toxicology and Applied Pharmacology. 423:115578

Sotorasib is a first-in class KRASG12C covalent inhibitor in clinical development for the treatment of tumors with the KRAS p.G12C mutation. In the nonclinical toxicology studies of sotorasib, the kidney was identified as a target organ of toxicity i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::45d6d22122d0a5df18503b33a0a2156a
https://doi.org/10.1016/j.taap.2021.115578

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Recommendations for Clinical Pathology Data Generation, Interpretation, and Reporting in Target Animal Safety Studies for Veterinary Drug Development

Autor: Aradhana Gupta, Lindsay Tomlinson, Niraj Tripathi, William Siska, Barbara von Beust

Publikováno v: International Journal of Toxicology. 36:293-302

Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5012657f7a28c43239900b64b6c35ce1
https://doi.org/10.1177/1091581817711876

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Identification of contaminant interferences which cause positive urine reagent test strip reactions in a cage setting for the laboratory-housed nonhuman primate, Beagle dog, and Sprague-Dawley rat

Autor: Catherine Brandoff, Dennis J. Meyer, William Siska, Albert E. Schultze

Publikováno v: Veterinary clinical pathology. 46(1)

Background A high incidence of unexplained positive urine reagent test strip reactions was observed in healthy, untreated laboratory-housed nonhuman primates, Beagle dogs, and Sprague-Dawley rats. Exposure of urine to cage pan contaminants was the su

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::91c4121fe094a39423becfd85f75b12c
https://pubmed.ncbi.nlm.nih.gov/28295488

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